RPS ADENO DETECTOR— 510(k) K052092

Substantially Equivalent

Rapid Pathogen Screening

FDA 510(k) clearance K052092 for RPS ADENO DETECTOR, Substantially Equivalent on 2005-11-22. Applicant: Rapid Pathogen Screening. Device class: 1.

Clearance details

Applicant: Rapid Pathogen Screening
Product code: Code GOD
Device class: Class 1
Regulation: 21 CFR 866.3020
Advisory panel: Microbiology
Date received: 2005-08-02
Decision date: 2005-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bradenton, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GOD

K110722 — RPS ADENO DETECTOR PLUS2011-05-17
K990630 — SAS ADENO TEST1999-08-19
K972406 — ADENOVIRUS ANTIGEN DETECTION ELISA TEST SYSTEM1997-12-22
K881894 — ADENOCLONE(R)-TYPE 40/41 EIA DIAGNOSTIC TEST (48)1988-07-08
K873082 — ADENOCLONE(TM)-EIA ADENOVIRUS ANTIGEN TEST1988-02-24

Data sourced from openFDA. This site is unofficial and independent of the FDA.